At a Glance
- Tasks: Shape and deliver quality frameworks in a pioneering biotech environment.
- Company: Innovative UK-based biotech with strong funding and a novel therapeutic pipeline.
- Benefits: High-impact role with opportunities for professional growth and development.
- Other info: Fast-paced environment with exposure to senior leadership.
- Why this job: Join a dynamic team and make a real difference in early clinical development.
- Qualifications: Experience in GCP QA and supporting early clinical studies required.
The predicted salary is between 50000 - 70000 £ per year.
Your new company
You will be supporting an innovative UK-based biotech entering first-in-human studies, backed by strong funding and progressing a novel therapeutic pipeline into early clinical development. The organisation is at a pivotal stage, building out its clinical and quality infrastructure as it transitions toward the clinic.
Your new role
As a GxP QA Consultant (GCP led), you will play a key role in shaping and delivering the organisation's quality framework, with a primary focus on GCP but with exposure across broader GxP disciplines (GLP / GMP depending on pipeline and scope).
Key responsibilities will include:
- Supporting the development and streamlining of GCP SOPs
- Providing QA oversight of CROs and clinical vendors
- Conducting and supporting GCP audits (internal/vendor/study-level)
- Driving inspection readiness (MHRA/FDA/EMA)
- Advising on phase appropriate QMS build without overengineering
This is a high-impact role, working closely with senior leadership in a growing biotech environment.
What you’ll need to succeed
- Proven experience within GCP QA in biotech or pharma environments
- Strong background supporting early clinical / FIH studies
- Experience building or improving QMS frameworks and SOPs
- Hands-on experience with audits and vendor oversight
- Ability to work autonomously in a fast-paced, evolving environment
What you’ll get in return
Opportunity to support a biotech at a critical inflection point.
GCP QA Consultant (Contract) employer: Hays Life Sciences
Join a pioneering UK-based biotech firm at the forefront of innovative therapeutic development, where your expertise as a GCP QA Consultant will directly influence the quality framework during a transformative phase. With a strong emphasis on employee growth and collaboration, you will thrive in a dynamic work culture that values your contributions while enjoying the unique opportunity to shape the future of clinical research. This role not only offers competitive benefits but also places you at the heart of a mission-driven organisation dedicated to advancing healthcare solutions.
StudySmarter Expert Advice🤫
We think this is how you could land GCP QA Consultant (Contract)
✨Tip Number 1
Network like a pro! Reach out to your connections in the biotech and pharma sectors. Attend industry events or webinars to meet potential employers and get your name out there. Remember, it’s all about who you know!
✨Tip Number 2
Prepare for interviews by researching the company thoroughly. Understand their pipeline and recent developments. This will help you tailor your answers and show that you’re genuinely interested in their work.
✨Tip Number 3
Showcase your hands-on experience! Be ready to discuss specific examples of how you've improved QMS frameworks or conducted audits. Use the STAR method (Situation, Task, Action, Result) to structure your responses.
✨Tip Number 4
Don’t forget to apply through our website! We’ve got loads of opportunities that might just be the perfect fit for you. Plus, it’s a great way to ensure your application gets seen by the right people.
We think you need these skills to ace GCP QA Consultant (Contract)
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the GCP QA Consultant role. Highlight your experience in biotech or pharma, especially with early clinical studies. We want to see how your background aligns with our needs!
Showcase Relevant Skills:When writing your application, emphasise your skills in developing GCP SOPs and conducting audits. We’re looking for someone who can hit the ground running, so make it clear how you can contribute from day one.
Be Clear and Concise:Keep your application clear and to the point. Use bullet points where possible to make it easy for us to see your key achievements and experiences. We appreciate a straightforward approach!
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. We can’t wait to hear from you!
How to prepare for a job interview at Hays Life Sciences
✨Know Your GCP Inside Out
Make sure you brush up on your Good Clinical Practice (GCP) knowledge. Be ready to discuss specific examples from your past experiences where you've implemented GCP guidelines, especially in early clinical studies. This will show that you’re not just familiar with the theory but have practical insights to offer.
✨Showcase Your Audit Experience
Prepare to talk about your hands-on experience with audits. Think of a few key audits you've conducted or been involved in, and be ready to explain your role, the challenges faced, and how you ensured compliance. This will demonstrate your capability in QA oversight and your understanding of the audit process.
✨Demonstrate Your QMS Knowledge
Since building or improving Quality Management Systems (QMS) is crucial for this role, come prepared with examples of how you've contributed to QMS frameworks in the past. Highlight any specific SOPs you've developed or streamlined, as this will show your proactive approach to quality assurance.
✨Be Ready for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills in a fast-paced environment. Think about potential challenges in GCP QA and how you would address them. This will help interviewers see your critical thinking and adaptability, which are essential in a growing biotech setting.
